recurrent or metastatic nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Gemcitabine, nedaplatin chemotherapy combined with apatinib
controll group:gemcitabine and nedaplatin chemotherapy
Sponsors
Guizhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years. 2. Life expectancy> 3 months. 3. Recurrent or metastatic nasopharyngeal carcinoma diagnosed by histopathology. Patients with metastases must obtain metastasis pathology for a clear diagnosis if the patient's condition, lesion site, and technical conditions permit; if metastasis pathology cannot be obtained, they need to stay Take imaging records of symptom records and metastases 4. Primary metastatic or recurrent nasopharyngeal carcinoma that is not suitable for local or radical treatment. 5. ECOG score 0-1. 6. Patients with relapsed or metastatic nasopharyngeal carcinoma who fail after first-line chemotherapy. 7. At least 3 months interval from the last chemo. 8. At least one measurable lesion according to RECIST 1.1 solid tumor evaluation criteria. 9. Normal bone marrow function: neutrophil> 1.5 x 10^9 / L, hemoglobin> 90g / L and platelet count> 100x10^9 / L 10. normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) 60 ml / min. 12. Subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. History of malignant tumors in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer or cervical carcinoma in situ. 2. Accompanied by severe concomitant diseases, which may bring greater risks or affect the compliance of the trial. For example: drug-uncontrollable hypertension, grade III-IV cardiac dysfunction, severe arrhythmia (QTc interval prolonged by 500m / s), severe hepatorenal dysfunction: urine protein >= ++, 24-hour urine protein> 1.0g ,mental illness. 3. Used other targeted drugs against VEGF / VEGFR. 4. Patients affected by oral administration for any reason (eg, inability to swallow, nausea, vomiting, chronic diarrhea, etc.). 5. CT / MRI indicates severe spinal cord compression. 6. Abnormal blood coagulation function, with bleeding tendency (APTT greater than 1.5 x ULN or INR> 1.5 x ULN), such as active peptic ulcer, or receiving thrombolytic or anticoagulation. 7. Arteriovenous thromboembolic events, such as cerebrovascular events, including transient ischemic attacks, deep vein thrombosis, and pulmonary embolism in the past 6 months. 8. Myocardial infarction, unstable angina, cardiac angioplasty, or stent implantation in the last 3 months 9. The lesion has obvious vascular invasion. 10. Use anticoagulants such as warfarin or heparin. If INR <= 1.5, treatment is interventional, low-dose warfarin (1 mg qd orally) or heparin (80 mg-100 mg qd) are allowed. 11. Patients who have not undergone major healing in the past month. 12. Women during pregnancy or breastfeeding (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment). 13. history of organ transplant. 14. Patients deemed by other treating physicians unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity;RECIST efficacy evaluation; | — |
Countries
China
Contacts
Public ContactLi yuanyuan
Guizhou Cancer Hospital
Outcome results
None listed